作者
Sharon E Frey, Michael Houghton, Stephen Coates, Sergio Abrignani, David Chien, Domenico Rosa, Piero Pileri, Ranjit Ray, Adrian M Di Bisceglie, Paola Rinella, Heather Hill, Mark C Wolff, Viola Schultze, Jang H Han, Bruce Scharschmidt, Robert B Belshe
发表日期
2010/8/31
期刊
Vaccine
卷号
28
期号
38
页码范围
6367-6373
出版商
Elsevier
简介
BACKGROUND
Hepatitis C virus (HCV) causes chronic liver disease that often leads to cirrhosis and hepatocellular carcinoma. In animal studies, chimpanzees were protected against chronic infection following experimental challenge with either homologous or heterologous HCV genotype 1a strains which predominate in the USA and Canada. We describe the first in humans clinical trial of this prophylactic HCV vaccine.
METHODS
HCV E1E2 adjuvanted with MF59C.1 (an oil-in-water emulsion) was given at 3 different dosages on day 0 and weeks 4, 24 and 48 in a phase 1, placebo-controlled, dose escalation trial to healthy HCV-negative adults.
RESULTS
There was no significant difference in the proportion of subjects reporting adverse events across the groups. Following vaccination subjects developed antibodies detectable by ELISA, CD81 neutralization and VSV/HCV pseudotype neutralization. There were …
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SE Frey, M Houghton, S Coates, S Abrignani, D Chien… - Vaccine, 2010